On March 8, 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 134).
CADTH Common Drug Review Submissions May Be Filed up to 180 Days before Market Authorization
In support of the Health Canada’s Regulatory Review of Drugs and Devices (R2D2) initiative and to promote alignment between CADTH’s Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) processes, CADTH will now be accepting CDR submissions up to 180 calendar days in advance of the anticipated receipt of a Notice of Compliance (NOC) or Notice of Compliance with Conditions (NOC/c) from Health Canada. This represents an increase from the current pre-NOC threshold of 90 calendar days.
This process is effective for any CDR submissions filed on or after April 2, 2018. As the embargoed recommendation will not be issued until CADTH has received the NOC or NOC/c, there may be situations where CADTH is unable to issue the embargoed CDEC recommendation within 180 calendar days due to category 1 requirements being incomplete. In such circumstances, the manufacturer will not be entitled to a refund.
Reminder: Articles with Supplemental Data and Appendices
CADTH would like to remind applicants to please ensure that copies of any supplemental data and appendices from published studies are included in CDR submission and resubmission packages.
For more information, please refer to the CADTH website.